ph-0080
print Print Back Back

Leuprolide Suspension: Lupron Depot®, Lupron Depot-Ped®, Eligard®, Fensolvi®, Camcevi™

Policy Number: PH-0080

Intramuscular/Subcutaneous

 

Last Review Date: 03/01/2022

Date of Origin: 11/28/2011

Dates Reviewed: 12/11, 03/2012, 06/2013, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 5/2016, 8/2016, 11/2016, 2/2017, 5/2017, 8/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 06/2020, 04/2021, 07/2021, 08/2021, 03/2022

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization
  • Endometriosis:
    • Coverage will be provided for 6 months and may be renewed one time only.
  • Prevention/Management of Menstrual Bleeding:
    • Coverage will be provided for 6 months and may NOT be renewed.
  • Uterine Leiomyomata (fibroids):
    • Coverage will be provided for 3 months and may NOT be renewed.
  • Fertility Preservation:
    • Coverage will be provided for 12 months and may be renewed while patient is receiving concomitant cytotoxic chemotherapy.
  • All Other Indications: Coverage will be provided for 12 months and may be renewed.
  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

B. Max Units (per dose and over time) [HCPCS Unit]:

Drug Name

Strength

Quantity

Days Supply

Lupron Depot 1-Month

3.75 mg

1 injection

28 days

Lupron Depot 1-Month

7.5 mg

1 injection

28 days

Lupron Depot 3-Month

11.25 mg

1 injection

84 days

Lupron Depot 3-Month

22.5 mg

1 injection

84 days

Lupron Depot 4-Month

30 mg

1 injection

112 days

Lupron Depot 6-Month

45 mg

1 injection

168 days

Lupron Depot-Ped 1-month

7.5 mg

1 injection

28 days

Lupron Depot-Ped 1-month

11.25 mg

1 injection

28 days

Lupron Depot-Ped 3-Month

11.25 mg

1 injection

84 days

Lupron Depot-Ped 1-month

15 mg

1 injection

28 days

Lupron Depot-Ped 3-Month

30 mg

1 injection

84 days

Eligard

7.5 mg

1 injection

28 days

Eligard

22.5 mg

1 injection

84 days

Eligard

30 mg

1 injection

112 days

Eligard

45 mg

1 injection

168 days

Fensolvi

45 mg

1 injection

168 days

Camcevi

42 mg

1 injection

168 days

Diagnosis

HCPCS

Product(s)

Billable Units

Days Supply

Prostate/Breast/ Ovarian Cancer

J9217

Lupron Depot 1-Month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Lupron Depot 4-Month & Eligard 30 mg

4

112

Lupron Depot 6-Month & Eligard 45 mg

6

168

Head and Neck Cancer – Salivary Gland Tumors

J9217

Lupron Depot 1-month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Breast/Ovarian Cancer; Endometriosis; Uterine Fibroids

J1950

Lupron Depot 1-Month 3.75 mg

1

28

Lupron Depot 3-Month 11.25 mg

3

84

Central Precocious Puberty

J1950/ J1951

Lupron Depot-Ped 7.5 mg

2

28

Lupron Depot-Ped 11.25 mg

3

28

Lupron Depot-Ped 15 mg

4

28

Lupron Depot-Ped 30 mg

8

84

Fensolvi 45 mg Kit

180

168

Prostate Cancer

J1952

Camcevi 42 mg Kit

(42 mg)

168

Fertility Preservation/ Prevention/Management of Menstrual Bleeding

J1950

Lupron Depot 1-Month 3.75 mg

1

28

Gender Dysphoria

J1950/ J1951

Lupron Depot 1-Month 3.75 mg

1

28

Lupron Depot 3-Month 11.25 mg

3

84

Lupron Depot-Ped 11.25 mg

3

28

Fensolvi 45 mg Kit

180

168

  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age (unless otherwise specified); AND

Central Precocious Puberty (CPP) 3,6,12,18-20Ф (J1950 and J1951 [Fensolvi only])

  • Patient is less than 13 years of age; AND
  • Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation; AND
  • Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native growth hormone-releasing hormone (GnRH); AND
  • Bone age advanced greater than 2 standard deviations (SD) beyond chronological age; AND
  • Tumor has been ruled out by lab tests such as diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), and human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor) ; AND
  • Will not be used in combination with growth hormone

Endometriosis 1,2,10 †  (J1950 only)

  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)

Uterine Leiomyomata (fibroids) 1,2,11(J1950 only)

  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
  • Documentation patient is receiving iron therapy

Breast Cancer 8,9,13,14(J9217 and J1950)

  • Patient is premenopausal or is a male with suppression of testicular steroidogenesis; AND
  • Disease is hormone receptor-positive; AND
    • Used in combination with adjuvant endocrine therapy; OR
    • Used in combination with endocrine therapy for recurrent unresectable or metastatic disease

Ovarian Cancer 8,9,16,17(J9217 and J1950)

  • Used as a single agent; AND
    • Patient has a diagnosis of stage II-IV granulosa cell tumors of the ovary; AND
      • Patient has relapsed disease; OR
    • Patient has a diagnosis of Epithelial Ovarian Cancer OR Fallopian Tube Cancer OR Primary Peritoneal Cancer; AND
      • Patient has persistent or recurrent disease (excluding immediate treatment of biochemical relapse)

Prostate Cancer 4,5,8,9,15(J9217 and J1952 [Camcevi only])

  • Patient has advanced disease (Camcevi only)

Head and Neck Cancer 8,9(J9217 only)

  • Patient has salivary gland tumors; AND
  • Used as a single agent; AND
  • Patient has androgen-receptor positive recurrent disease; AND
    • Patient has distant metastases with a performance status score of 0-3; OR
    • Patient has unresectable locoregional recurrence or second primary with prior radiation therapy

Prevention/Management of Menstrual Bleeding Associated with Hematopoetic Stem Cell Transplant (HCT) 22-25(J1950 only)

  • Patient is premenopausal; AND
    • Patient will receive conditioning myeloablative treatment with cytotoxic chemotherapy; OR
    • Patient has menorrhagia due to thrombocytopenia related to delayed platelet engraftment

Fertility Preservation Prior to Chemotherapy 22-25(J1950 only)

  • Patient is premenopausal; AND
  • Patient is receiving treatment with cytotoxic chemotherapy with the potential to cause ovarian damage/toxicity (e.g., cyclophosphamide, melphalan, procarbazine vinblastine,imatinib, etc.); AND
  • Patient has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation, etc.)

Gender Dysphoria (formerly Gender Identity Disorder) 26,27 (J1950 and J1951 [Fensolvi only])

  • Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP)**  OR the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria §; AND
  • A qualified MHP** has confirmed all of the following:
    • Patient has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed); AND
    • Gender dysphoria worsened with the onset of puberty; AND
    • Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment; AND
    • Patient has sufficient mental capacity to give informed consent to this (reversible) treatment; AND
  • Patient has been informed of the effects and side effects of treatment (including potential loss of fertility if the individual subsequently continues with sex hormone treatment) and options to preserve fertility; AND
  • Patient has given informed consent and (particularly when the adolescent has not reached the age of legal medical consent, depending on applicable legislation) the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process; AND
  • A pediatric endocrinologist or other clinician experienced in pubertal assessment has confirmed all of the following:
    • Agreement in the indication for treatment; AND
    • Puberty has started in the adolescent (e.g., Tanner stage ≥G2/B2); AND
    • There are no medical contraindications to treatment

**  Definition of a qualified mental health professional 28

  • A master’s degree or its equivalent in a clinical behavioral science field. This degree or a more advanced one should be granted by an institution accredited by the appropriate national or regional accrediting board. The mental health professional should also have documented credentials from the relevant licensing board or equivalent; AND
  • Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the International Classification of Diseases for diagnostic purposes; AND
  • Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria; AND
  • Knowledgeable about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria; AND
  • Continuing education in the assessment and treatment of gender dysphoria. This may include attending relevant professional meetings, workshops, or seminars; obtaining supervision from a mental health professional with relevant experience; or participating in research related to gender nonconformity and gender dysphoria.

§ DSM-V Criteria for Gender Dysphoria 26,27

  • A marked incongruence between one’s experienced/expressed gender and natal gender of at least 6mo in duration, as manifested by at least TWO of the following:
    • A marked incongruence between one’s experienced/expressed gender and primary and/or secondary sex characteristics (or in young adolescents, the anticipated secondary sex characteristics)
    • A strong desire to be rid of one’s primary and/or secondary sex characteristics because of a marked incongruence with one’s experienced/expressed gender (or in young adolescents, a desire to prevent the development of the anticipated secondary sex characteristics)
    • A strong desire for the primary and/or secondary sex characteristics of the other gender
    • A strong desire to be of the other gender (or some alternative gender different from one’s designated gender)
    • A strong desire to be treated as the other gender (or some alternative gender different from one’s designated gender)
    • A strong conviction that one has the typical feelings and reactions of the other gender (or some alternative gender different from one’s designated gender); AND
  • The condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning; AND
  • Specify one of the following:
    • The condition exists with a disorder of sex development; OR
    • The condition is posttransitional, in that the individual has transitioned to full-time living in the desired gender (with or without legalization of gender change) and has undergone (or is preparing to have) at least one sex-related medical procedure or treatment regimen—namely, regular sex hormone treatment or gender reassignment surgery confirming the desired gender (e.g., penectomy, vaginoplasty in natal males; mastectomy or phalloplasty in natal females).

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

  1. Renewal Criteria

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: tumor flare, hyperglycemia/diabetes, cardiovascular disease (myocardial infarction, sudden cardiac death, stroke), QT/QTc prolongation, convulsions, etc.; AND

Prostate Cancer (J9217 and J1952 [Camcevi only]);

Head and Neck Cancer – Salivary Gland Tumors (J9217 only);

Breast and Ovarian Cancer (J9217 or J1950 only)

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND

Central Precocious Puberty (CPP)  3,6,12,18-20 (J1950 and J1951 [Fensolvi only])

  • Patient is less than 13 years of age; AND
  • Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, a decrease in the ratio of bone age to chronological age (BA:CA), and improvement in final height prediction; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: convulsions, development or worsening of psychiatric symptoms, etc.; AND
  • Will not be used in combination with growth hormone

Gender Dysphoria 26,27

  • Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters

Endometriosis (J1950 only)

  • Patient has not received a total of 12 months of therapy of a GnRH-agonist (i.e., leuprolide acetate, etc.); AND
  • Patient continues to have symptoms of endometriosis or symptoms recur after the initial 6-month course of therapy; AND
  • Patient will have bone density assessment prior to retreatment; AND
  • Extended GnRH-agonist treatment will be used in combination with norethindrone add-back therapy

Uterine Leiomyomata (fibroids) (J1950 only)

  • Coverage may NOT be renewed

Prevention/Management of Menstrual Bleeding Associated with HCT (J1950 only)

  • Coverage may NOT be renewed

      Fertility Preservation Prior to Chemotherapy (J1950 only)

  • Patient is still receiving treatment with cytotoxic chemotherapy
  1. Dosage/Administration 1-7

Indication

Dose

Endometriosis

Administer 3.75 mg intramuscularly monthly or 11.25 mg intramuscularly every 3 months for a duration of 6 months only.

Breast/Ovarian Cancer

Administer, intramuscularly or subcutaneously, 3.75 mg every/7.5 mg monthly or 11.25 mg/22.5 mg every 3 months.

Central Precocious Puberty (CPP)

  • Fensolvi subcutaneous kit
  • Administer 45 mg subcutaneously once every 6 months.
  • Lupron Depot-Ped intramuscular injection:
  • Weight based:
  • >37.5 kg: 15 mg every 4 weeks
  • >25-37.5 kg: 11.25 mg every 4 weeks
  • ≤ 25 kg: 7.5 mg every 4 weeks; OR
  • Ages 2 to 11 yrs: 11.25 mg or 30 mg every 12 weeks

Uterine Leiomyomata (fibroids)

Administer 3.75 mg intramuscularly monthly or 11.25 mg intramuscularly every 3 months*.

*The recommended duration of therapy is 3 months or less; retreatment is dependent on the return of symptoms.

Prostate Cancer

  • Lupron Depot & Eligard
  • Administer, intramuscularly or subcutaneously, 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks, 45 mg every 24 weeks, or 42 mg every 24 weeks.
  • Camcevi subcutaneous kit
  • Administer 42 mg subcutaenously once every 6 months.

Salivary Gland tumors of the Head and Neck

Administer, intramuscularly or subcutaneously, 7.5 mg every 4 weeks, 22.5 mg every 12 weeks

Prevention/Management of Menstrual Bleeding Associated with HCT

Administer 3.75 mg intramuscularly once every 4 weeks up to 6 months

Therapy should be started 4-5 weeks prior to conditioning chemotherapy and continued as required until platelets are >50,000 post HCT)

Fertility Preservation Prior to Chemotherapy

Administer 3.75 mg intramuscularly every 4 weeks

Gender Dysphoria

  • Lupron Depot injection:
  • Administer 3.75 mg intramuscularly once a month in combination with transdermal estradiol 1 or 2 mg/day; OR
  • Administer 11.25 mg subcutaneously every 3 months
  • Fensolvi subcutaneous kit
  • Administer 45 mg subcutaneously once every 6 months

Note:

  • Lupron Depot is administered intramuscularly (IM), Eligard, Fensolvi, and Camcevi are administered subcutaneously (SQ)
  • Camcevi must be administered by a healthcare provider.
  • Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.
  1. Billing Code/Availability Information

Drug Name

Strength

HCPCS*

NDC

Lupron Depot 1-Month

3.75 mg

J1950

00074-3641-xx

Lupron Depot 1-Month

7.5 mg

J9217

00074-3642-xx

Lupron Depot 3-Month

11.25 mg

J1950

00074-3663-xx

Lupron Depot 3-Month

22.5 mg

J9217

00074-3346-xx

Lupron Depot 4-Month

30 mg

J9217

00074-3683-xx

Lupron Depot 6-Month

45 mg

J9217

00074-3473-xx

Lupron Depot-Ped

7.5 mg

J1950

00074-2108-xx

Lupron Depot-Ped

11.25 mg

J1950

00074-2282-xx

Lupron Depot-Ped 3-Month

11.25 mg

J1950

00074-3779-xx

Lupron Depot-Ped

15 mg

J1950

00074-2440-xx

Lupron Depot-Ped 3-Month

30 mg

J1950

00074-9694-xx

Eligard

7.5 mg

J9217

62935-0753-xx

Eligard

22.5 mg

J9217

62935-0223-xx

Eligard

30 mg

J9217

62935-0303-xx

Eligard

45 mg

J9217

62935-0453-xx

Fensolvi

45 mg

J1951

62935-0153-xx

Camcevi

42 mg

J1592

72851-0042-xx

*J1950: Injection, leuprolide acetate (for depot suspension), per 3.75 mg

*J9217: Leuprolide acetate (for depot suspension), 7.5 mg

*J1951: Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg

*J1952: Leuprolide injectable, camcevi, 1 mg

  1. References
  1. Lupron Depot GYN 3 Month 11.25 mg [package insert]. North Chicago, IL; Abbvie Inc.; March 2020. Accessed February 2022.
  2. Lupron Depot GYN 3.75 mg and 3 Month 11.25 mg [package insert]. North Chicago, IL; Abbvie Inc.; February 2021. Accessed February 2022
  3. Lupron Depot-Ped [package insert]. North Chicago, IL; Abbvie Inc.; March 2021. Accessed February 2022.
  4. Lupron Depot URO [package insert.]. North Chicago, IL; Abbvie Inc.; March 2019.  Accessed February 2022.
  5. Eligard [package insert]. Fort Collins, CO; Tolmar Therapeutics, Inc; April 2019.  Accessed February 2022.
  6. Fensolvi [package insert]. Fort Collins, CO; Tolmar Therapeutics, Inc; May 2020.  Accessed February 2022.
  7. Camcevi [package insert]. Taipei City, Taiwan; Foresee Pharmaceuticals Co., Ltd.; May 2021.  Accessed February 2022.
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Leuprolide acetate. National Comprehensive Cancer Network, 2022.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2022.
  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Leuprolide acetate for depot suspension. National Comprehensive Cancer Network, 2022.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org.  Accessed February 2022.
  10. Dlugi AM, Miller JD, Knittle J, et al: Lupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a randomized, placebo-controlled, double-blind study. Fertil Steril 1990; 54:419-427.
  11. Friedman AJ, Barbieri RL, Doubilet PM, et al: A randomized, double-blind trial of a gonadotropin-releasing hormone agonist (leuprolide) with or without medroxyprogesterone acetate in the treatment of leiomyomata uteri. Obstet Gynecol Surv 1988; 43:484-485.
  12. Lee PA & Page JG: The Leuprolide Study Group: Effects of leuprolide in the treatment of central precocious puberty. J Pediatr 1989; 114:321-324.
  13. Harvey HA, Lipton A, Max DT, et al: Medical castration produced by the GnRH analogue leuprolide to treat metastatic breast cancer. J Clin Oncol 1985; 3:1068-1072.
  14. Boccardo F, Rubagotti A, Amoroso D, et al, “Endocrinological and Clinical Evaluation of Two Depot Formulations of Leuprolide Acetate in Pre- and Perimenopausal Breast Cancer Patients,” Cancer Chemother Pharmacol, 1999, 43(6):461-6.
  15. National Collaborating Centre for Cancer. Prostate cancer: diagnosis and treatment. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Feb. 146 p. (NICE clinical guideline; no. 58)
  16. Fishman A, Kudelka AP, Tresukosol D, et al. Leuprolide acetate for treating refractory or persistent ovarian granulosa cell tumor. J Reprod Med. 1996;41(6):393-396.
  17. Kavanagh JJ, Roberts W, Townsend P, et al: Leuprolide acetate in the treatment of refractory or persistent epithelial ovarian cancer. J Clin Oncol 1989; 7:115-118.
  18. Beccuti G, Ghizzoni L. Normal and Abnormal Puberty. Endotext. De Groot LJ, Chrousos G, Dungan K, et al., editors, South Dartmouth (MA): MDText.com, Inc.; 2000-. Accessed at: https://www.ncbi.nlm.nih.gov/books/NBK279024/.
  19. Brito VN, Spinola-Castro AM, Kochi C, et al. Central precocious puberty: revisiting the diagnosis and therapeutic management. Arch Endocrinol Metab. 2016 Apr;60(2):163-72
  20. Carel JC, Eugster E, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.
  21. Shore N, Mincik I, DeGuenther M, et al. A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients. World J Urol. 2020 Jan;38(1):111-119. doi: 10.1007/s00345-019-02741-7.
  22. Amsterdam A, et al. Management of menorrhagia. Treatment of menorrhagia in women undergoing hematopoietic stem cell transplantation. Bone Marrow Transplantation 2004; 34:363-66..
  23. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Adolescent and Young Adult (AYA) Oncology Version 2.2022. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2022.
  24. Options for Prevention and Management of Menstrual Bleeding in Adolescent Patients Undergoing Cancer Treatment: ACOG Committee Opinion, Number 817. Obstet Gynecol. 2021 Jan 1;137(1):e7-e15. doi: 10.1097/AOG.0000000000004209.
  25. Ghalie, R., et al. Prevention of Hypermenorrhea with Leuprolide in Premenopausal Women Undergoing Bone Marrow Transplantation, American Journal of Hematology. 1993;42: 350-353.
  26. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102:3869
  27. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association Publishing.
  28. The World Professional Association for Transgender Health (WPATH), Standards of Care for the Health of Transsexual, and Gender Nonconforming People. Seventh Version. July 2012. Available at: https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341
  29. Hembree WC, Cohen-Kettenis PT, Gooren L, et al; Endocrine treatment of gender-dysphoric/gender-incongruent persons: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102(11):3869-3903.
  30. Gava G, Cerpolini S, Martelli V, et al; Cyproterone acetate vs leuprolide acetate in combination with transdermal oestradiol in transwomen: a comparison of safety and effectiveness. Clin Endocrinol (Oxf) 2016; 85(2):239-246.
  31. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A57655). Centers for Medicare & Medicaid Services, Inc. Updated on 11/21/2019 with effective date 10/03/2018. Accessed February 2022.
  32. National Government Services, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453).  Centers for Medicare & Medicaid Services, Inc.  Updated on 12/22/2021 with effective date 01/01/2022. Accessed February 2022.
  33. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776). Centers for Medicare & Medicaid Services, Inc.  Updated on 10/08/2021 with effective date 10/01/2021. Accessed February 2022.

Appendix 1 – Covered Diagnosis Codes

J1950

ICD-10

ICD-10 Description

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

D25.0

Submucous leiomyoma of uterus

D25.1

Intramural leiomyoma of uterus

D25.2

Subserosal leiomyoma of uterus

D25.9

Leiomyoma of uterus, unspecified

E30.1

Precocious puberty

E30.8

Other disorders of puberty

F64.0

Transsexualism

F64.1

Dual role transvestism

F64.2

Gender identity disorder of childhood

F64.8

Other gender identity disorders

F64.9

Gender identity disorder, unspecified

N80.0

Endometriosis of uterus

N80.1

Endometriosis of ovary

N80.2

Endometriosis of fallopian tube

N80.3

Endometriosis of pelvic peritoneum

N80.4

Endometriosis of rectovaginal septum and vagina

N80.5

Endometriosis of intestine

N80.6

Endometriosis in cutaneous scar

N80.8

Other endometriosis

N80.9

Endometriosis, unspecified

N93.8

Other specified abnormal uterine and vaginal bleeding

N94.89

Other specified conditions associated with female genital organs and menstrual cycle

T86.09

Other complications of bone marrow transplant

Z31.84

Encounter for fertility preservation procedure

J9217

ICD-10

ICD-10 Description

C06.9

Malignant neoplasm of mouth, unspecified

C07

Malignant neoplasm of parotid gland

C08.0

Malignant neoplasm of submandibular gland

C08.1

Malignant neoplasm of sublingual gland

C08.9

Malignant neoplasm of major salivary gland, unspecified

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C61

Malignant neoplasm of prostate

Z85.43

Personal history of malignant neoplasm of ovary

Z85.46

Personal history of malignant neoplasm of prostate

J1951 (Fensolvi only)

ICD-10

ICD-10 Description

E30.1

Precocious puberty

E30.8

Other disorders of puberty

F64.0

Transsexualism

F64.1

Dual role transvestism

F64.2

Gender identity disorder of childhood

F64.8

Other gender identity disorders

F64.9

Gender identity disorder, unspecified

J1952 (Camcevi only)

ICD-10

ICD-10 Description

C61

Malignant neoplasm of prostate

Z85.46

Personal history of malignant neoplasm of prostate

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Lupron Depot/Lupron Depot-Ped (J1950) & Lupron Depot/Eligard (J9217)

Jurisdiction(s):  N

NCD/LCD Document (s): A57655

 https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57655&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

 https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52453&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s):  H

NCD/LCD Document (s): A56776

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56776&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

LEUPROLIDE SUSP (Lupron Depot®, Lupron Depot-Ped®, Eligard®, Fensolvi®) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2022, Magellan Rx Management

White MRx.PNG